Recon: Abbvie Settles Humira Patent Dispute With Sandoz; BMS’ Opdivo Fails in Ph. III Lung Cancer Study

• Abbvie settles Humira patent disputes with Novartis unit (Reuters) (Fierce) (Big Molecule Watch) (Endpoints)
• US appeals court upholds ruling that canceled Teva Copaxone patents (Reuters)
• Feds charge 5 New York doctors with prescribing 8.5 million opioid pills (NBC) (NYTimes) (WSJ)
• A biotech company misled investors about its dealings with FDA (STAT) (Endpoints)
• Trevena's opioid injection fails to win over FDA committee (Pharmafile) (Medpage)
• Bristol-Myers concedes a PhIII lung cancer flop for Opdivo as competition heats up in SCLC (Endpoints) (Reuters) (Fierce) (Press)
• In public, lawmakers scold drug distributors. Come campaign season, they accept their cash willingly (STAT)
• Pfizer pays $700,000 to settle charges over misleading copay coupons (STAT) (Law360-$) (Reuters)
• AbbVie staves off another US Humira knockoff to 2023 as European launch looms
• FDA expands Xarelto use to patients with coronary artery disease and peripheral artery disease (Press) (PharmaTimes)
• Public seems to know value of clinical trials, but not how they work (Reuters)
• Percentage of young US children who don’t receive any vaccines has quadrupled since 2001 (Washington Post) (NBC)
• FDA approves new DNA-based test to determine blood compatibility (FDA)
• Merck ditches biosimilar Lantus, but will that ease the path for Mylan’s rival insulin product? (Fierce)
• Shire opens $1.2B Georgia plant to make rare disease drugs (Fierce)

• Merck KGaA posts mixed data from their big PhIIb MS study on evobrutinib — spurring plenty of questions (Endpoints)
• FDA And EU Regulators Find Data Integrity Lapses Are Still A Major GMP Problem (Pink Sheet-$)
• No-Deal Brexit Means ‘Re-Planning A Whole Industry,’ Says ABPI Chief (Pink Sheet-$)
• Nordic Procurement Deal Signals New Weapons In Fight For Lower Prices (Pink Sheet-$)
• CHMP delays decision on Kiadis’ GVHD immunotherapy (PMLive)
• UK Appeal Panel Tells NICE To Revisit Scenesse Rejection (Pink Sheet-$)
• Samsung BioLogics opens third plant, contemplates a fourth in Korea (BioPharmaReporter)
• Coroner calls on MHRA to take action over 'inherently unsafe' EpiPen (Pharmaceutical Journal)
• EU validates Repligen’s marketing application for fostamatinib (PharmaTimes)
• Indian Govt gets ready to revise Schedule M to make it on par with WHO-GMP standards (PharmaBiz)
• Korean approval for Opdivo in RCC combination (PharmaLetter-$)
• EMA To Discuss Reactivating Landmark Clinical Trials Transparency Policy (Pink Sheet-$)
• Chanelle Pharma announces €86m investment over next five years (Pharmafile)

• Aetna, CVS, Walgreens, And Amazon May Finally Let Pharma Do What It Does Best (Forbes)
• Fake friends at the FDA, cancer counter-narratives, and biotech’s bear turn (STAT)
• BIO Has Big Diversity Goals. Does It Have the Means to Reach Them? (Xconomy)
• Proposed Provisions for a Draft NIH Data Management and Sharing Policy (NIH)
• Drug repurposing: progress, challenges and recommendations (Nature)
• FDA approves Stiolto Respimat sNDA (PharmaLetter-$)
• Cancer stem cell pipeline flounders (Nature)
• Regulatory T cells in the treatment of disease (Nature)
• Hoth Therapeutics seeks IPO cash to battle eczema (Fierce)
• Inter Partes Review To Be More Favorable To Biotech (BioCentury)
• Tired Of Winning? When It Comes To US FDA Appeals, “Denied” Can Still Mean Victory (Pink Sheet-$)
• Rare HIV PrEP Failure Reported in San Francisco (Medpage)
• Seeking cash to fund PhIII for once-failed drug, Adynxx rides Alliqua’s shell to Nasdaq (Endpoints) (Fierce)
• Immune Design buries its PhIII work on cancer, and investors hit the panic button (Endpoints)
• FDA draft guidance on generic-delaying citizen petitions a ‘warning shot’ to industry, lawyer says (MedCity)

• Phase II Data For Merck's BTK Inhibitor Highlighted At ECTRIMS (BioCentury) (SCRIP-$)
• MaaT Pharma Announces First Patient Dosed in Phase 2 Clinical Trial of Lead Product MaaT013, a First-in-Class Biotherapeutic to Treat Acute GvHD (Press)
• Ipsen to present new data from its oncology portfolio at the 2018 European Society for Medical Oncology (ESMO) congress (Press)
• Gilead to Present Wide-Ranging New Data on Treatment and Diagnosis of Liver Diseases at The Liver Meeting 2018 (Press)
• Arrowhead to Present Late-Breaking Clinical Data on ARO-AAT and ARO-HBV at AASLD Liver Meeting 2018 (Press)

• If at First You Don’t Succeed, Try, Try, Try Again: FDA Issues Plan to Increase Efficiency of 510(k) Third Party Review Program (FDA Law Blog)
• FDA Continues Its Press On Medical Device Cybersecurity (Drug & Device Law)
• Boston Scientific touts 3-year Solyx stress urinary incontinence mesh trial data (MassDevice)
• Securing legacy medical devices is daunting – but not optional (mobihealthnews)
• FDA to revamp medtech cybersecurity — with your help (Medical Design & Outsourcing)
• With $4.5B, Q3 2018 was digital health funding's biggest quarter yet (mobihealthnews)

• Alex Azar for attorney general? HHS says no way (Politico)
• Investor suits against AbbVie pile up in wake of Humira kickback allegations (Fierce)
• Jury clears J&J of liability in New Jersey talc cancer case (Reuters)
• Judge may overturn $289 million verdict in Monsanto Roundup case (CBS)
• FDA advances investigation into whether more than 40 e-cigarette products are being illegally marketed and outside agency's compliance policy (FDA)

• FDA Advisory Committee Calendar

• Early access to medicines scheme applications: pending, refused, granted (MHRA)
• Marketing authorisations granted in September 2018 (MHRA)
• Parallel import licenses granted in September 2018 (MHRA)

• Looming questions for Japan pharma (PharmaLetter-$)
• AmoyDx Lung Cancer CDx Approved in South Korea (GenomeWeb)

• Maharashtra FDA to urge Centre to bring amendments in D&C Act for better compliance (PharmaBiz)

• Canada clears Medtronic’s MiniMed 670G insulin pump (MassDevice)

• Submissions received and TGA response: Complaints Handling - Advertising therapeutic goods to the public (TGA)